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氟胞嘧啶注射液稳定性预测

PREDICTION OF STABILITY OF FLUCYTOSINE INJECTIONS

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【作者】 胡育筑张奕华李丰文江声华侯秀清

【Author】 HU Yu-Zhu, ZHANG Yi-Hua, LI Feng-Wen, JIANG Sheng-Hua and HOU Xiu-Qing(China Pharmaceutical University, Nanjing)

【机构】 中国药科大学中国药科大学 南京南京南京

【摘要】 <正> 氟胞嘧啶为5-氟-4-氨基-2(1 H)-嘧啶酮(简称5-FC),系近年来发展起来的新型抗真菌药。Florey曾介绍薄层—紫外分光光度法测定氟胞嘧啶的含量,研究其制剂的稳定性,但其原文未见公开发表。本文报告应用反相离子对色谱法测定注射液中氟胞嘧啶的含量,并按照化学动力学方法预测氟胞嘧啶注射液的稳定性。

【Abstract】 Kinetics of hydrolysis of flueytosine (5-FC) was discussed to predict the stability of flucytosine injections. Reverse phase ion-pair HPLC was used to determine 5-FC in flucytosine injections. The stability of the injections was examined with the classical isothermal method. The use of HPLC made it possible to determine the different contents of 5-FC in the presence of its degradation products. According to Arrhenius rule, the activation energy of 5-FC was 27.8 kcal. mol-1. Since its main degradation product——fluorouracil is the factor in flucytosine clinical toxicity, shelf life was calculated in t0.999 and t0.998. At 25℃ it was about half a year (t0.999) and 1.5 years (t0.998). At 15~20℃ it was about 1.5 years (t0.999) and about 3 years (t0.998).

【关键词】 氟胞嘧啶氟脲嘧啶稳定性
【Key words】 FlucytosineFluorouracilStability
  • 【文献出处】 药学学报 ,Acta Pharmaceutica Sinica , 编辑部邮箱 ,1987年06期
  • 【被引频次】1
  • 【下载频次】61
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